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Generated: May 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207322

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NDA 207322 describes POLYMYXIN B SULFATE, which is a drug marketed by X Gen Pharms, West-ward Pharms Int, Gland Pharma Ltd, Paddock Llc, Xellia Pharms Aps, Fresenius Kabi Usa, and Aurobindo Pharma Ltd, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the POLYMYXIN B SULFATE profile page.

The generic ingredient in POLYMYXIN B SULFATE is polymyxin b sulfate. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate profile page.

Summary for NDA: 207322

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 207322


Suppliers and Packaging for NDA: 207322

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
polymyxin b sulfate
INJECTABLE;INJECTION 207322 ANDA Breckenridge Pharmaceutical, Inc. 51991-939 51991-939-17 10 VIAL, SINGLE-USE in 1 CARTON (51991-939-17) > 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-USE (51991-939-99)
polymyxin b sulfate
INJECTABLE;INJECTION 207322 ANDA Gland Pharma Limited 68083-174 68083-174-10 10 VIAL in 1 CARTON (68083-174-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (68083-174-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500,000 UNITS BASE/VIAL
Approval Date:Apr 14, 2016TE:APRLD:No

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